Duns Number:016898496
Device Description: Magic3 Go® Intermittent Urinary Catheter
Catalog Number
51812
Brand Name
Magic3 Go™ Intermittent Urinary Catheter
Version/Model Number
51812
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
2aed8b98-5407-4076-b2c0-84f66be7a9e7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 08, 2015
Package DI Number
10801741097871
Quantity per Package
30
Contains DI Package
00801741097874
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 472 |
2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
U | Unclassified | 10 |